510(k) K934831 ยท IZH System, X-Ray, Mammographic
ADVANCED AUTOMATIC KV
| Applicant | Elscint, Inc., Hackensack NJ, US |
| Decision | Substantially Equivalent, Aug 23, 1994 |
| Received | Oct 8, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934831
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.